Study design
As this research examines a newly developed intervention, its pilot effectiveness can be assessed with a non-randomized study using a small number of samples [16]. Therefore, this study was a one-group pre-test–post-test design. The 14 participants were divided into two groups of 7 people each. To increase the cohesion of the treatment groups, we attempted to make each of the groups approximately equal in terms of age and gender. Once the treatment groups were established, they were presented with the intervention in 12 weekly 2-hour sessions. Measurements were taken in three stages: before the start of the intervention, shortly after the end of the intervention, and three months after the intervention (three-month follow-up). To prepare participants for entering the group therapy sessions, an informational interview was conducted with each member to clarify the group's goals and expectations before the start of the treatment sessions. Treatment was provided at the Saye Sare Omid Clinic in Tehran, Iran. Participants were enrolled between December 2021 and April 2022. This study was conducted by the principles of the Declaration of Helsinki and was conducted according to the Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) statement [17]. Ethical approval was obtained by the Ethics Committee of Allameh Tabataba'i University (IR.ATU.REC.1400.076; Date: 05/03/2022). For more information about the ethical certificate, please click on the following link: https://ethics.research.ac.ir/form/w8w7vr8dacicbng.pdf
Participants
To encourage voluntary participation in this study, several newsletters were placed in the research section of the Divar® marketing application. People who lived in Tehran and whose chief complaint was depression were screened and entered into an online interview if they received initial approval. Of the hundreds of people who attended the initial screening, more than 50 people participated in an online interview using the Persian version of the SCID-5 [18] after signing informed consent forms. A clinical psychologist with a Ph.D. educational level and 10 years of experience in evaluating and treating depression, administered the online interview. Of 31 volunteers who met the study entry criteria and gave informed consent, 14 participants between the ages of 22 and 40 finally participated. Inclusion criteria were: age from 18 to 60 years (ability to perform computerized cognitive exercises); receiving the diagnosis of MDD based on the DSM-5; the existence of at least one cognitive dysfunction (a standard deviation or more below the average) in cognitive tests; and injecting at least two doses of the COVID-19 vaccine. Patients with a history of receiving CBT within the last 2 years, simultaneous participation in other psychological and medical therapies, comorbid personality and/or psychotic disorders, a history of mania or hypomania, active substance abuse, active suicidal ideation, and lack of stability on psychiatric medication (hence at least 3 months) are excluded. Table 2 shows the characteristics and preliminary diagnoses of eligible candidates to participate in this study.
Table 2
Characteristics and preliminary diagnoses of eligible candidates to participate in the research
|
Number of patients/mean (SD)
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Gender M/F
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12/19
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Age based on years (mean ± SD)
|
33.93 (9.59)
|
BDI-II scores
|
|
Mild
|
6
|
Moderate
|
20
|
Severe
|
5
|
Comorbidity
|
|
Agoraphobia
|
4
|
Attention deficit/hyperactivity disorder
|
4
|
Body Dysmorphic disorder
|
6
|
Eating Disorder
|
2
|
Generalized anxiety disorder
|
13
|
Hair-pulling disorder
|
1
|
Hoarding Disorder
|
1
|
Illness Anxiety disorder
|
2
|
Obsessive-compulsive disorder
|
2
|
Panic disorder
|
4
|
Separation anxiety disorder
|
4
|
Social anxiety disorder
|
6
|
Somatic symptom disorder
|
2
|
Specific phobias
|
3
|
Intervention
To develop a treatment based on hot and cold cognition model of depression [10], we reviewed the previous research to determine whether empirically supported, manual-based interventions exist to address the treatment of MDD. For this purpose, the words MDD, CBT, depression, unipolar depression, CRT, cognitive rehabilitation, cognitive training, cold cognition, hot cognition, CI, cognitive dysfunction, and cognitive deficits were googled individually or in combination. Also, an extensive literature review was conducted to identify manualized interventions for MDD and CI, regardless of setting or population. Among these sources, the most important was an article on the hot and cold cognitive model of depression [10], the books “Treatment plans and interventions for depression and anxiety disorders” [19], and “Cognitive remediation for psychological disorders” [20], which became the basis for developing a new fitting manual for patients with MDD. In addition, the recommendations and techniques suggested in other articles and books were used [21]. Finally, CBT and CRT were selected as the best baseline manuals for fitting patients with MDD [7].
Table 3 shows an overview of the manual goals of the group CBT + CRT in the sessions. The treatment consists of 12 sessions, which are carried out in a group setting. Each session lasts 2 hours, the first half is a CBT session and the second half is a CRT session. There is a 15-minute break between these two.
Table 3
An overview of the manual goals of the group CBT + CRT in the sessions
Sessions
|
CBT goals
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CRT goals
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Session 1
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Introducing group members to each other and building relationships; general explanation of the treatment process; increasing knowledge about depression, exploring the depressive symptoms of group members; and evaluating the cognitive, behavioral, and interpersonal aspects of group members’ depression
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Session 2
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Determining treatment goals, introducing CBT, beginning behavioral intervention such as behavioral activation, and introducing depression from the perspective of hot and cold cognition
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Introducing CRT, collecting adequate information about learning style, cognitive difficulties, and personal interest areas, setting a program and plan for the meeting, beginning CCT exercises in the sessions and at home, and involving group members in the CRT process
|
Session 3
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Eliminating suicidal thoughts, reducing frustration and automatic negative thoughts, and increasing self-reward for performing positive behaviors (once a day)
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Informal assessment of cognitive abilities, setting the CRT goals, introducing some of the cognitive abilities, doing CCT exercises, identifying the need for external structure, increasing motivation and involvement with exercises
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Session 4
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Engaging in a rewarding activity (once a day), reducing automatic negative thoughts and mental ruminations
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Identifying the best tasks that engage the group members, doing CCT exercises, and providing corrective feedback to increase failure tolerance and processing speed
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Session 5
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Reducing automatic negative thoughts and mental ruminations; increasing social communications (once a week); teaching problem-solving and communication skills
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Teaching recall techniques, doing CCT exercises (increasing the complexity of the cognitive tasks), and emphasizing minor changes as a promising technique
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Session 6
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Assertive training, increasing social communications (twice a week), and modifying inefficient hypotheses
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Teaching recall techniques, and doing CCT exercises (increasing the complexity of the cognitive tasks, such as doing logic exercises).
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Session 7
|
Increasing social communications (three times a week), continuing the goals of previous sessions, and modifying inefficient hypotheses and the worthless schema (or others’ schema)
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Beginning CCT exercises at all levels (skill, fluency, and application); a conversation about psychological factors that affect cognitive performance; and bridging the gap between acquisitions and real-life expectations (metacognitive groups).
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Session 8
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Continuing the goals of previous sessions and modifying inefficient hypotheses and the worthless schema (or others’ schema)
|
Doing CCT exercises at all levels, having conversations about psychological factors that affect cognitive performance, and bridging the gap between acquisitions and real-life expectations (metacognitive groups).
|
Session 9
|
Continuing the goals of previous sessions and modifying inefficient hypotheses and the worthless schema (or others’ schema)
|
Doing CCT exercises at all levels and bridging the gap between acquisitions and real-life expectations (metacognitive groups)
|
Session 10
|
Continuing the goals of previous sessions and modifying inefficient hypotheses and the worthless schema (or others’ schema)
|
Doing CCT exercises at all levels and bridging the gap between acquisitions and real-life expectations (problem-solving groups)
|
Session 11
|
Continuing the goals of previous sessions and modifying inefficient hypotheses and the worthless schema (or others’ schema)
|
Doing CCT exercises at all levels and bridging the gap between acquisitions and real-life expectations (problem-solving groups)
|
Session 12
|
The teaching of relapse prevention skills
|
Doing CCT exercises at all levels and bridging the gap between acquisitions and real-life expectations (problem-solving groups)
|
The goals and related interventions of the group CBT + CRT were as follows: (1) reduce anhedonia: reward and activity scheduling, self-rewarding, graded task assignment, and challenging unpleasant thoughts; (2) mental rumination reduction: antecedent-behavior-consequence analysis, activity scheduling, graded task assignment, objectifying thought, problem-solving, worry postponement, teaching communication and assertiveness, a behavioral experiment, and mindfulness training; (3) modify emotional processing: cognitive restructuring, mindfulness training, positive self-talk, and thought stopping; (4) cognitive bias modification: cognitive restructuring, cognitive defusion, positive cognitive activities, self-review technique, and mindfulness training; (5) self-care: sleep hygiene, time management, a healthy diet, and social support; (6) improving social communication (three times a week): social skills training, and reward and activity scheduling; (7) reducing despair and eliminating suicidal thoughts: reviewing causes of despair, checking evidence for and against despair, behavioral experiments, activity scheduling, cognitive restructuring, making changes to achieve meaning, arranging a contract to contact the therapist, creating coping strategies against suicidal impulses, creating short and long-term goals; (8) acquisition of relapse prevention skills: review and practice learned techniques as needed; and (9) cognitive remediation: using a Neuropsychological and Educational Approach to Remediation (NEAR) and computerized cognitive training (CCT) with Brain Challenge® and Senior Game®, two android games.
Measurements
The Structured Clinical Interview for DSM-5 (SCID-5)
The SCID-5 is a semi-structured interview manual covering the core diagnostics of the DSM-5. One of the most important applications of the SCID-5 is to select a study population. The reliability and validity of the Persian version of SCID-5 were investigated for a variety of diagnoses in a variety of clinical settings, and the results indicated their acceptability [18].
The Beck Depression Inventory (BDI-II)
It is a 21-item test that measures the severity of depressive symptoms on a four-point scale from 0 to 63. This questionnaire is a screening tool that can be implemented individually or in groups. The validity and reliability of this tool in a study were investigated. Validity was reported in terms of Cronbach's alpha coefficients from 0/73 to 0/92 and reliability was reported from 0/48 to 0/86[22].
Snaith-Hamilton Pleasure Scale (SHAPS)
The SHAPS has 14 items that measure the capacity and ability to obtain pleasure. This scale can be used in both clinical and research fields. By reading each statement on a spectrum of four options, the respondent shows his agreement or disagreement with each statement. Recently, Ebrahimi et al. [23] investigated the validity and reliability of this questionnaire and reported that this test has appropriate validity and reliability.
THINC-it test
This test is a digital neuropsychological assessment tool that is specifically designed to evaluate the cognitive functions of people with depression and includes four objective cognitive tests whose validity has already been well investigated. These tests include the Spotter (choice reaction time; a reaction time test of attention), the Symbol Check (1-back test; a working memory test), the Trails (Trails Making Test B; an executive function test), and the Codebreaker (Digit Symbol Substitution Test; a coding test that measures a variety of cognitive skills). McIntyre et al. [24] in a study investigated the THINC-it tool’s sensitivity to change in adults with MDD. The results demonstrate that the THINC-it scores are highly correlated with improvements in the pencil and paper versions of the Digit Symbol Substitution Test (DSST) and the Trails Making Test B (TMTB). As a result, the THINC-it is an appropriate tool for demonstrating health outcome improvements in MDD patients.
Data Analysis
Intervention data were only analyzed for participants who remained in the study through session 12 and were absent for no more than two sessions during those sessions. In this context, first, the descriptive statistics of the changes in the BDI-II, SHAPS, and THINC-it scores were calculated, then the variability and Cohen’s d effect size were calculated.
Sample Size
Using G*Power, sufficient sample size was calculated [25] based on a t-test (matched pairs). To assess the favored effectiveness, at least 10 participants were required by assuming a two-tailed test, an effect size of 1, an alpha error probability of 0.05, and a power of 0.8. The basic effect size was obtained from a study, in which the effect sizes for group CBT on the depressive symptoms were 0.97 and 1.10 in post-treatment and follow-up, respectively [26].