Behavior Therapy for Adjustment Disorder

Overseen By Stephanie M Hart, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Active psychosis, Suicidal ideation, Severe substance use

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 6 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to treat Adjustment Disorder (AjD), a common mental health issue among military personnel that arises after extreme stress events like losing a comrade or suffering a serious injury. Researchers compare two types of therapy: Transdiagnostic Behavior Therapy (TBT) and the usual Problem Solving Therapy (TAU-PST), to determine which more effectively reduces symptoms. Participants will receive six therapy sessions, each lasting 30-45 minutes. Eligible participants have served or are serving in the military and have a current diagnosis of Adjustment Disorder. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance mental health care for military personnel.

Will I have to stop taking my current medications?

The trial requires that participants have been on stable psychotropic medication (medications affecting mood, perception, or behavior) for at least 4 weeks, so you may not need to stop taking your current medications if they are stable.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Transdiagnostic Behavior Therapy (TBT) is safe and generally well-received by patients. Studies have found that TBT can improve symptoms as effectively as Behavioral Activation Treatment for Depression (BATD). Additionally, patients often attend and complete more TBT sessions, indicating a positive experience.

For Treatment as Usual - Problem Solving Therapy (TAU-PST), specific safety data isn't provided here. However, as it is commonly used for stress-related issues, it is generally considered safe.

Overall, both TBT and TAU-PST involve talking and problem-solving, which are usually low-risk compared to medication. While no treatment is entirely without risk, these therapies are designed to be supportive and manageable for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Transdiagnostic Behavior Therapy (TBT) for Adjustment Disorder because it offers a flexible approach that targets underlying processes common across various mental health conditions, rather than focusing on disorder-specific symptoms. This makes it adaptable and potentially more effective for individuals experiencing a range of emotional challenges. Additionally, TBT is designed to be delivered in a concise format with just six sessions, which may lead to faster benefits compared to traditional therapies that often require longer treatment periods. This method could revolutionize how we address Adjustment Disorder by streamlining therapy while maintaining effectiveness.

What evidence suggests that this trial's treatments could be effective for Adjustment Disorder?

Research has shown that Transdiagnostic Behavior Therapy (TBT), one of the treatments studied in this trial, might help reduce symptoms in people with Adjustment Disorder. Studies have found TBT effective for treating major depression and anxiety, indicating its potential usefulness for various emotional issues, including those seen in Adjustment Disorder. In contrast, Treatment as Usual-Problem Solving Therapy (TAU-PST), another treatment option in this trial, is a common therapy that helps people manage everyday problems and stress. While researchers study TBT for its broader effects, TAU-PST remains a reliable option for managing stress-related symptoms. ^{1 2 3 4 6}

Who Is on the Research Team?

Ron Acierno, PhD

Principal Investigator

McGovern Medical School at UTHealth Houston

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have served or are serving in the military and have been diagnosed with Adjustment Disorder after a traumatic event. They must be stable on any psychotropic medication for at least four weeks. Those with active psychosis, serious thoughts of suicide, or severe substance use issues cannot participate.

Inclusion Criteria

My mental health medication has not changed in the last 4 weeks.

I have been diagnosed with Adjustment Disorder.

Exclusion Criteria

Suicidal ideation with clear intent

Active psychosis

Severe substance use

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 6 sessions of either Transdiagnostic Behavior Therapy (TBT) or Treatment as Usual-Problem Solving Therapy (TAU-PST)

6 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Assessments at baseline, post-treatment, 3-month, and 6-month follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Transdiagnostic Behavior Therapy
• Treatment as Usual-Problem Solving Therapy

Trial Overview The study compares Transdiagnostic Behavior Therapy (TBT) to the usual treatment, which is Moving Forward Problem Solving Therapy (TAU-PST), to see which is more effective in reducing symptoms of Adjustment Disorder in military personnel.

How Is the Trial Designed?

Group I: Transdiagnostic Behavior Therapy (TBT) Experimental Treatment 1 Intervention

Participants will receive 6, 30-45-minute, manualized, individual therapy sessions.

Group II: Active Comparator: Treatment as Usual-Problem Solving Therapy (TAU-PST) Active Control 1 Intervention

Participants will receive 6, 30-45-minute, manualized, individual therapy sessions.

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

U.S. Army Medical Research and Development Command

Collaborator

Trials

296

Recruited

249,000+

Ralph H. Johnson VA Medical Center

Collaborator

Trials

21

Recruited

5,700+

Published Research Related to This Trial

Transdiagnostic behavior therapy (TBT) was effective in reducing various forms of avoidance in 44 veterans with emotional disorders, showing moderate-to-large effect sizes for situational, thought, and positive emotional avoidance.

The study highlights TBT's potential to address transdiagnostic symptoms across different emotional disorders, contributing valuable insights to the effectiveness of transdiagnostic treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of transdiagnostic behavior therapy on transdiagnostic avoidance in veterans with emotional disorders. Gros, DF., Shapiro, MO., Allan, NP.[2023]

Transdiagnostic Behavior Therapy (TBT) was developed and evaluated for veterans with affective disorders, showing significant improvements in symptoms of depression, anxiety, stress, and posttraumatic stress in a study involving 29 participants.

The initial support for TBT was informed by earlier findings from a smaller group of 15 veterans, indicating that a single treatment approach can effectively address multiple related disorders in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and initial evaluation of Transdiagnostic Behavior Therapy (TBT) for veterans with affective disorders. Gros, DF.[2021]

A study comparing Acceptance and Commitment Therapy (ACT) and Cognitive Behavioral Therapy (CBT) in a psychiatric day hospital with 253 participants showed that both therapies significantly improved everyday functioning and health-related quality of life, as well as reduced anxiety and depressive symptoms.

The results indicated that ACT-based treatment is as effective as CBT for patients with psychiatric and physical health conditions, making it a valuable option in routine hospital care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and commitment-based therapy for patients with psychiatric and physical health conditions in routine general hospital care - Development, implementation and outcomes. Burian, H., Böge, K., Burian, R., et al.[2021]

Group transdiagnostic behavior therapy (TBT) was found to be feasible and effective for youths aged 16-19 with anxiety disorders, showing significant improvements in anxiety symptoms after 12 sessions.

While TBT led to moderate reductions in anxiety and stress, the effects on depression and overall impairment were less reliable, suggesting that further research with larger samples is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Findings for Group Transdiagnostic Behavior Therapy for Affective Disorders Among Youths. Gros, DF., Merrifield, C., Hewitt, J., et al.[2022]

Transdiagnostic cognitive behavioral therapy (CBT) protocols have been developed to streamline treatment for affective disorders by combining overlapping components from various disorder-specific CBT approaches, potentially reducing the number of protocols needed.

These newer transdiagnostic treatments, such as group CBT for anxiety and the unified protocol for emotional disorders, aim to address multiple symptoms and comorbidities simultaneously, making CBT more accessible and cost-effective for both providers and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Movement towards transdiagnostic psychotherapeutic practices for the affective disorders. Gros, DF., Allan, NP., Szafranski, DD.[2018]

Transdiagnostic cognitive-behavioral therapy (CBT) is an adaptable treatment that can effectively address a variety of anxiety and emotional disorders, potentially improving accessibility for patients.

Clinical trials and meta-analyses indicate that transdiagnostic CBT is as effective as traditional CBT, and may be particularly beneficial for individuals with multiple anxiety and emotional disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transdiagnostic Therapy. Norton, PJ., Roberge, P.[2018]

In a study involving 109 participants with affective disorders, group Transdiagnostic Behaviour Therapy (TBT) showed significant improvements in psychiatric symptoms and transdiagnostic impairment, suggesting its effectiveness as a treatment option.

While TBT did not statistically outperform disorder-specific group therapies in all symptoms, it demonstrated about twice the treatment effect size in reducing transdiagnostic impairment and significantly improved comorbid depressive symptoms in patients with social anxiety disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Naturalistic Comparison of Group Transdiagnostic Behaviour Therapy (TBT) and Disorder-Specific Cognitive Behavioural Therapy Groups for the Affective Disorders. Gros, DF., Merrifield, C., Rowa, K., et al.[2019]

In a study involving 231 participants with anxiety disorders, combining transdiagnostic group cognitive-behavioral therapy (tCBT) with treatment-as-usual (TAU) significantly reduced anxiety symptoms compared to TAU alone, as measured by the Beck Anxiety Inventory and clinician severity ratings.

The results showed a substantial effect size (Cohen's d = 0.76 for BAI and 0.79 for ADIS-5), indicating that tCBT is an effective addition to standard care for improving anxiety disorder symptoms in community mental health settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group transdiagnostic cognitive-behavior therapy for anxiety disorders: a pragmatic randomized clinical trial. Roberge, P., Provencher, MD., Gaboury, I., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06433271

Transdiagnostic Behavior Therapy Vs TAU for Adjustment ... The investigators will compare the effects of Transdiagnostic Behavior Therapy (TBT) vs treatment as usual which is Moving Forward Problem Solving Therapy (TAU- ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38041148/

Effectiveness and mediators of change of an online CBT ... The study aims to determine the effectiveness of an online transdiagnostic cognitive behavioural intervention for students experiencing adjustment disorder.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10034572/

A comparison of transdiagnostic behavior therapy (TBT) ... The present findings support TBT as an efficacious treatment for principal major depressive disorder, with potentially superior coverage of comorbid anxiety ...

4. nature.com nature.com/articles/s41562-023-01787-3

A systematic review and meta-analysis of transdiagnostic ... Here we investigate short- and long-term efficacy of TD-CBT for emotional disorders in individual, group and internet-based settings in ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0272735825001096

Together and beyond: A systematic review on ... Meta-analytic findings consistently demonstrate that group therapy is not only effective compared to non-active treatments, but also yields outcomes equivalent ...

6. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2774513

Effectiveness of Transdiagnostic Cognitive-Behavioral ... A transdiagnostic modular cognitive-behavioral therapy (CBT) program outperform management as usual for youth with emotional and behavioral problems.